Congressional:

Government Shuts Down After Congress Failed to Pass Short-Term Funding Bill

On Wednesday, the government shut down after Congress failed to pass a bill to fund the government. Last week, the House passed a short-term continuing resolution (CR) (H.R. 5371) largely along party lines to fund the government through November 21. On Wednesday, the Senate voted again on H.R. 5371 but failed to reach the 60-vote threshold needed to pass the bill.  The impasse came after Democratic leaders pushed for an extension of the Affordable Care Act’s (ACA) advanced premium tax credits (APTCs), set to expire this year, to be included in the CR, as well as repealing Medicaid provisions that were included in the One Big Beautiful Bill Act, while Republicans pushed for a clean seven-week stopgap spending bill. Democrats argued that an extension needs to be passed as part of government funding now because insurers are setting rates for the upcoming year. After a bipartisan meeting on Monday between congressional leaders and President Trump failed to produce a deal on a funding extension, White House officials opened the door to possible bipartisan negotiations over an extension of the APTCs, but Vice President JD Vance also suggested that a shutdown would impede those talks.

Senator Sanders Releases Report on Prescription Drugs

On Monday, Senator Bernie Sanders (I-VT), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a new report that found that prices for 688 prescription drugs have increased since the start of the second Trump administration. The report also found that 87 drugs increased in price, by a median of 8%, after Trump sent letters to drug manufacturers asking for lower prescription drug prices. Read the press release here and the report here. 

Notable Bills Introduced:

Senators Marshall & Reed Introduce Legislation to Increase Cancer Screening Options for Rural Communities

On Monday, Senators Roger Marshall, M.D. (R-KS) and Jack Reed, M.D. (D-RI) introduced the Mobile Cancer Screening Act. The legislation would establish a federal grant program for hospitals and healthcare centers to increase the availability of detection services in rural and underserved communities. With these funds, providers can purchase mobile screening units, bringing potentially life-saving screening to the doorsteps of patients who are affected by a lack of transportation or long travel distances to clinics. Read the press release here and the bill here. 

Executive Branch:

HHS Government Shutdown Staff Plan

On Wednesday, government funding expired, resulting in a shutdown. More than 32,000 staffers, or roughly 41 percent of the Department of Health and Human Services’ (HHS) workforce, will be furloughed according to department contingency plans made public Monday. Services across the various HHS agencies are impacted differently:

• Centers for Disease Control and Prevention (CDC): About two-thirds of CDC staff will be furloughed. The agency will continue its responses to urgent outbreaks, but it will cease coordination with state and local health departments on opioid overdose prevention, HIV prevention, and diabetes prevention. The agency will not communicate health-related information to the public, and responses to public inquiries about public health matters will be suspended.
• National Institutes of Health (NIH): The NIH would retain roughly 25 percent of its staff. Operations at the NIH Clinical Center will mostly continue, but other basic research activities are paused.
• Centers for Medicare & Medicaid Services (CMS): Federal health insurance programs, including Medicare and Medicaid, are considered mandatory and will continue. The agency will also retain essential staff to process Children’s Health Insurance Program (CHIP) payments to eligible states.
• Food and Drug Administration (FDA): Most of the FDA’s staff will continue to work, and the agency will still support food and drug reviews. However, the FDA will limit the number of inspections it conducts, unless they are deemed necessary to address imminent threats to public health and safety. FDA Commissioner Marty Makary told agency staff that workers would be exempt from mass Reduction in Force (RIF) during the shutdown.

President Trump Announces First Most-Favored-Nation Pricing Deal

On Tuesday, President Trump announced an agreement with Pfizer to lower prescription drug costs by aligning prices with those paid in other developed nations through a most-favored-nation (MFN) pricing model. The deal gives state Medicaid programs access to MFN prices on existing Pfizer products and guarantees MFN prices on all new medicines Pfizer brings to market. It also requires Pfizer to repatriate increased foreign revenue on existing products that Pfizer realizes as a result of new trade policies to American Patients.  In addition, Pfizer will offer certain drugs directly to consumers through a new direct purchasing platform, TrumpRx.gov, with savings ranging as high as 85% and, on average, 50%. Pfizer gains tariff protections for three years, under the condition that the company continues to ramp up investments in U.S. manufacturing. Specific terms of the agreement remain confidential. Read the White House Fact sheet here and the Pfizer press release here.

President Trump Announces Tariffs on Pharmaceuticals

Late last week, on Thursday, September 25, Trump announced on Truth Social that brand-name or patented pharmaceutical products will be subject to a 100% tariff starting October 1 unless the pharmaceutical company is building a manufacturing plant in the U.S.  Reporting indicates those tariffs are now on pause to allow time to negotiate deals with individual companies.

In response to President Trump, Pharmaceutical Research and Manufacturers of America (PhRMA) announced on Monday, September 29, that its member companies would invest $500 billion in new U.S.-based infrastructure projects, creating more than 100,000+ new jobs. PhRMA also announced the launch of a new website, which will link patients with pharmaceutical direct purchase programs starting in January 2026.

President Trump Announces EO Prioritizing AI Innovation to Facilitate Cures for Pediatric Cancer

On Tuesday, President Trump signed an Executive Order (EO) to advance the use of artificial intelligence in the development of cures and prevention strategies for pediatric cancer, and to leverage health data in conjunction with AI to help transform clinical research and practice. The EO instructs the Make America Health Again (MAHA) Commission to collaborate with the Assistant to the President for Science and Technology (APST) and the Special Advisor for AI and Crypto to develop innovative approaches to utilizing advanced technologies to enhance diagnoses, treatments, cures, and prevention strategies for pediatric and young adult cancer. The EO also directs increased investment from existing federal funds for the Childhood Cancer Data Initiative (CCDI). In response to the EO, the Department of Health and Human Services (HHS) announced a doubling of funding for its Childhood Cancer Data Initiative at the National Cancer Institute from $50 million to $100 million. Read the EO here, the White House fact sheet here, and the HHS press release here.

CMS Releases Final Guidance for Third Round of Medicare Drug Price Negotiations

On Tuesday, the Centers for Medicare & Medicaid Services (CMS) released final guidance for the third cycle of negotiations under the Medicare Drug Price Negotiation Program, which will occur during 2026 and may result in negotiated Maximum Fair Prices (MFPs) that would be effective beginning in 2028. The guidance incorporates stakeholder feedback, emphasizes transparency, and expands orphan drug protections introduced in the One Big Beautiful Bill Act (Public Law 119-21). It also clarifies processes for renegotiation and implementation in 2026, 2027, and 2028. In accordance with the Inflation Reduction Act of 2022 (IRA), CMS will select up to 15 additional negotiation-eligible drugs covered under Part D and/or payable under Part B for this third cycle of negotiations. CMS may also select drugs negotiated in the first or second cycles of negotiation to be renegotiated if those selected drugs meet specific eligibility and selection criteria. The guidance also shifts from prior draft guidance by including both Medicare Advantage (MA) encounter data and traditional Fee-for-Service (FFS) Part B claims in calculating Total Expenditures and ensures equitable treatment across Medicare Parts B and D for drug selection. Read the press release here and the fact sheet here.

CMS Announces Medicare Advantage and Medicare Prescription Drug Programs Expected to Remain Stable in 2026

Late last week on Friday, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program are expected to remain stable in 2026. Average premiums are projected to decline in both the MA and Part D programs from 2025 to 2026. The average monthly plan premium across all MA plans, which includes MA plans that provide prescription drug coverage and MA Special Needs Plans (SNPs), is estimated by CMS to decrease from $16.40 in 2025 to $14.00 in 2026. Benefit options will remain stable, including MA supplemental benefit offerings such as hearing, dental, and vision. Based on plans’ projections, enrollment in MA is projected to be 34 million in 2026, a decrease from 34.9 million in 2025, with MA enrollment representing approximately 48% of all people enrolled in Medicare, compared to 50% in 2025. Read the press release here.

New Section 232 Investigation on PPE & Medical Consumables, Equipment, and Devices

Late last week, on Wednesday, the Trump Administration initiated a new Section 232 investigation concerning personal protective equipment (PPE), medical consumables, and medical equipment/devices. Commerce is requesting information on current and projected demand, domestic production, the role of foreign supply chains, imports, and unfair trade practices, among other things, with comments due on October 17.

Scope of the investigation includes:

• PPE includes, but is not limited to, surgical masks, N95 respirators, gloves, gowns, and related medical parts and components.
• Medical Consumables refers to single-use or short-term-use items used for patient diagnosis, treatment, and prevention of conditions. This includes medical/surgical supplies (e.g., syringes and needles) and medical/surgical supplies (e.g., IV bags). 
• Medical Equipment refers broadly as durable equipment, tools, and machines used in healthcare to support patient care, including wheelchairs, crutches, and hospital beds, among other things.
• Medical Devices includes any instrument, apparatus, or machine used in the diagnosis, monitoring, or treatment of medical conditions. This includes pacemakers, heart valves, and hearing aids, among many others.